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The Effect of Dietary Intervention on Endothelial Glycocalyx in Psoriasis

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ClinicalTrials.gov Identifier: NCT05184699
Recruitment Status : Not yet recruiting
First Posted : January 11, 2022
Last Update Posted : April 13, 2022
Sponsor:
Information provided by (Responsible Party):
Ignatios Ikonomidis, University of Athens

Brief Summary:
The food supplement Endocalyx is considered to support the endothelial glycocalyx integrity by supplying sulfated polysaccharides, anti-oxidant enzymes and additional substrates for glycocalyx synthesis. The investigators will study the effect of Endocalyx on endothelial, vascular and left ventricular myocardial function in patients with psoriatic disease.

Condition or disease Intervention/treatment Phase
Psoriasis Dietary Supplement: Food supplement Endocalyx Dietary Supplement: Placebo Not Applicable

Detailed Description:
Sixty patients with psoriatic disease, who are referred to the outpatient psoriasis clinic of the Attikon University Hospital, will be randomized to receive food supplement Endocalyx (4 capsules per day) (n=30) or placebo (n=30) for 4 consecutive months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Sixty patients with psoriatic disease will be randomized to receive food supplement Endocalyx (n=30) or placebo (n=30) for 4 consecutive months.
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Dietary Intervention on Endothelial Glycocalyx Integrity and Microvascular Perfusion in Patients With Psoriatic Disease
Estimated Study Start Date : June 1, 2022
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Food supplement Endocalyx
Thirty patients with psoriatic disease will randomized to receive 4 capsules a day of the food supplement Endocalyx for 4 months
Dietary Supplement: Food supplement Endocalyx
Patients with psoriatic disease will be randomized to receive food supplement Endocalyx for 4 months.
Other Names:
  • Endocalyx
  • Q-prime

Placebo Comparator: Placebo
Thirty patients with psoriatic disease will randomized to receive 4 capsules a day of the placebo for 4 months
Dietary Supplement: Placebo
Patients with psoriatic disease will be randomized to receive placebo for 4 months.




Primary Outcome Measures :
  1. Endocalyx effects on endothelial glycocalyx thickness [ Time Frame: four months ]
    Endocalyx effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels using Sidestream Dark Field (SDF) imaging.


Secondary Outcome Measures :
  1. Endocalyx effects on arterial stiffness [ Time Frame: four months ]
    Endocalyx effects on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.

  2. Endocalyx effects on coronary microcirculation [ Time Frame: four months ]
    Endocalyx effects on coronary function as assessed by measuring coronary flow reserve of left anterior descending artery. Coronary flow reserve is estimated by Doppler echocardiography as the ratio of coronary flow velocity after bolus intravenous adenosine infusion to coronary flow velocity at rest.

  3. Endocalyx effects on left ventricular myocardial function [ Time Frame: four months ]
    Endocalyx effects on left ventricular function as assessed by global longitudinal strain using speckle-tracking echocardiography.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Caucasian patients with psoriatic disease (plaque-type psoriasis or psoriatic arthritis)
  • Body mass index ≥18.5 Kg/m2
  • If female, patients must be non-pregnant and non-breastfeeding

Exclusion Criteria:

  • History of acute coronary syndrome. Coronary artery disease will be excluded by a clinical history, examination and electrocardiogram.
  • Moderate or severe valve disease
  • Primary cardiomyopathies
  • Chronic obstructive pulmonary disease
  • Asthma
  • Chronic kidney disease
  • Liver failure
  • Malignancies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05184699


Contacts
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Contact: Ignatios Ikonomidis, Professor +302105832187 ignoik@gmail.com
Contact: George Pavlidis, PhD +302105832187 geo_pavlidis@yahoo.gr

Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Ignatios Ikonomidis, Professor 2nd Cardiology Department, National and Kapodistrian University of Athens
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Responsible Party: Ignatios Ikonomidis, Professor of Cardiology, University of Athens
ClinicalTrials.gov Identifier: NCT05184699    
Other Study ID Numbers: 672/2-12-2021
First Posted: January 11, 2022    Key Record Dates
Last Update Posted: April 13, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ignatios Ikonomidis, University of Athens:
psoriasis
endothelial glycocalyx
arterial stiffness
coronary microcirculation
left ventricular myocardial deformation
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases